Edentulous Alveolar RidgeNCT04915677
Edentulous Sites Augmented With Collagen Matrix or CTG
A study testing Soft tissue augmentation with subepithelial connective tissue graft (SCTG) and Soft tissue augmentation with xenogenic volume stable collagen matrix in people with Edentulous Alveolar Ridge, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Ridge deformities can complicate prosthetic rehabilitation, especially in situations where optimal esthetic outcomes are desired. Simpler, less invasive and predictable treatments are needed in order to obtain soft tissue augmentation at edentulous ridges. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Soft tissue augmentation with subepithelial connective tissue graft (SCTG) and Soft tissue augmentation with xenogenic volume stable collagen matrix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2021to 10 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Intercalated mono-edentulous area ridge defects to be rehabilitated with fixed partial bridge
- At least 18 years old
- At least 6 months from tooth extraction at the study area.
Who cannot join
- Systemic diseases which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus);
- Smoking ≥ 10 cigarettes a day;
- Pregnant or nursing women;
- Chronic use of corticosteroids or other anti-inflammatory or immune-modulator drugs;
- Patients who need use of medications affecting bone metabolism or oral mucosa;
- Presence of a congruous FDP at the edentulous area;
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- History of soft tissue augmentation surgery in the study area;
- Active periodontitis
- Uncompliant patients
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Turin
Turin
Giacomo Baima, DDS, 00393497254708, giacomo.baima@unito.it
About this study
Official title: Volumetric Changes at Edentulous Sites Augmented With Collagen Matrix or Connective Tissue Graft: a Randomized Clinical Trial With 6 Months Follow up
Ridge deformities can complicate prosthetic rehabilitation, especially in situations where optimal esthetic outcomes are desired. Simpler, less invasive and predictable treatments are needed in order to obtain soft tissue augmentation at edentulous ridges. Autogenous subepithelial connective tissue graft (SCTG) has always been regarded as the treatment of choice, but heterologous volume stable collagen matrix (VCMX) is emerging as a reliable alternative. The principal aim of the present RCT will be to compare the volumetric buccal soft tissue changes at edentulous areas after augmentation procedure using VCMX or SCTG. Parameters related to periodontal health at adjacent teeth and patient reported outcomes (PROMs) will be also assessed as secondary outcomes. Proving the non- inferiority of VCMX compared to SCTG would provide the specialists and general clinicians with an easier, less invasive and better tolerated technique for soft tissue augmentation at edentulous ridges and for improving aesthetic and cleansability of the prosthetic rehabilitation.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Soft tissue augmentation with subepithelial connective tissue graft (SCTG), Soft tissue augmentation with xenogenic volume stable collagen matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue augmentation with subepithelial connective tissue graft (SCTG)Procedure or surgery
After local anesthesia a mesio-distal crestal incision will be performed reaching the alveolar bone. Split thickness dissection performed both buccal and palatal. Subepithelial connective tissue graft will be harvested and inserted beneath the mucoperiosteal flap and stretched buccally and lingually using a modified horizontal mattress suture. The flap margins at the crest will be adapted using single interrupted sutures in order to achieve a primary closure of the flap.
Soft tissue augmentation with xenogenic volume stable collagen matrixProcedure or surgery
After local anesthesia a mesio-distal crestal incision will be performed reaching the alveolar bone. Split thickness dissection performed both buccal and palatal. Xenogenic volume stable collagen matrix will be inserted beneath the mucoperiosteal flap and stretched buccally and lingually using a modified horizontal mattress suture. The flap margins at the crest will be adapted using single interrupted sutures in order to achieve a primary closure of the flap.
| Study group | Role | What they receive |
|---|---|---|
| Subepithelial Connective Tissue Graft (SCTG) | Active comparator | Soft tissue augmentation at edentulous area with subepithelial connective tissue graft harvested from the patient's palate Receives: Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG) |
| Volume Stable Collagen Matrix (VCMX) | Experimental | Soft tissue augmentation at edentulous area with xenogenic volume stable collagen matrix Receives: Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)
Mean linear change in mm from baseline to 6 months follow-up
Measured: 6 months
Secondary outcomes (3)
Change in Probing Pocket Depth (PD) at adjacent teeth (0-15 mm with higher values representing worse outcomes)
The distance between cementoenamel junction (CEJ) and the base of the pocket
Measured: 6 months
Mucosal recession at adjacent sites (0-15 mm with higher values indicating worse outcomes)
The distance between the cementoenamel junction (CEJ) and the mucosal margin
Measured: 6 months
Pain (VAS scale)(0-10 with higher values indicating worse outcomes)
Subjective pain experienced by the patient expressed in a VAS scale
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start10 Jun 2021
- Primary completion10 Jun 2023 (estimated)
- Study completion10 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915677
- Sponsor's protocol ID
- GFGTurin1
- Status last verified
- Feb 2023
- First submitted
- 25 May 2021
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Changes at Edentulous Sites Augmented With Collagen Matrix or Connective Tissue Graft: a Randomized Clinical Trial With 6 Months Follow up
- ClinicalTrials.gov ID
- NCT04915677
- Acronym / sponsor ID
- GFGTurin1
- Conditions
- Edentulous Alveolar Ridge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 10 Jun 2023 (estimated)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ridge deformities can complicate prosthetic rehabilitation, especially in situations where optimal esthetic outcomes are desired. Simpler, less invasive and predictable treatments are needed in order to obtain soft tissue augmentation at edentulous ridges. Autogenous subepithelial connective tissue graft (SCTG) has always been regarded as the treatment of choice, but heterologous volume stable collagen matrix (VCMX) is emerging as a reliable alternative. The principal aim of the present RCT will be to compare the volumetric buccal soft tissue changes at edentulous areas after augmentation procedure using VCMX or SCTG. Parameters related to periodontal health at adjacent teeth and patient reported outcomes (PROMs) will be also assessed as secondary outcomes. Proving the non- inferiority of VCMX compared to SCTG would provide the specialists and general clinicians with an easier, less invasive and better tolerated technique for soft tissue augmentation at edentulous ridges and for improving aesthetic and cleansability of the prosthetic rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subepithelial Connective Tissue Graft (SCTG) | Active comparator | Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG)Soft tissue augmentation at edentulous area with subepithelial connective tissue graft harvested from the patient's palate |
| Volume Stable Collagen Matrix (VCMX) | Experimental | Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrixSoft tissue augmentation at edentulous area with xenogenic volume stable collagen matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intercalated mono-edentulous area ridge defects to be rehabilitated with fixed partial bridge
- At least 18 years old
- At least 6 months from tooth extraction at the study area.
Key exclusion criteria (9 listed)
- Systemic diseases which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus);
- Smoking ≥ 10 cigarettes a day;
- Pregnant or nursing women;
- Chronic use of corticosteroids or other anti-inflammatory or immune-modulator drugs;
- Patients who need use of medications affecting bone metabolism or oral mucosa;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft tissue augmentation with subepithelial connective tissue graft (SCTG)After local anesthesia a mesio-distal crestal incision will be performed reaching the alveolar bone. Split thickness dissection performed both buccal and palatal. Subepithelial connective tissue graft will be harvested and inserted beneath the mucoperiosteal flap and stretched buccally and lingually using a modified horizontal mattress suture. The flap margins at the crest will be adapted using single interrupted sutures in order to achieve a primary closure of the flap. | Procedure or surgery | Subepithelial Connective Tissue Graft (SCTG) |
| Soft tissue augmentation with xenogenic volume stable collagen matrixAfter local anesthesia a mesio-distal crestal incision will be performed reaching the alveolar bone. Split thickness dissection performed both buccal and palatal. Xenogenic volume stable collagen matrix will be inserted beneath the mucoperiosteal flap and stretched buccally and lingually using a modified horizontal mattress suture. The flap margins at the crest will be adapted using single interrupted sutures in order to achieve a primary closure of the flap. | Procedure or surgery | Volume Stable Collagen Matrix (VCMX) |
Primary outcome
Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)
Time frame: 6 months
Mean linear change in mm from baseline to 6 months follow-up
3 secondary outcomes
Change in Probing Pocket Depth (PD) at adjacent teeth (0-15 mm with higher values representing worse outcomes)
Time frame: 6 months
Mucosal recession at adjacent sites (0-15 mm with higher values indicating worse outcomes)
Time frame: 6 months
Pain (VAS scale)(0-10 with higher values indicating worse outcomes)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft tissue augmentation with subepithelial connective tissue graft (SCTG) and Soft tissue augmentation with xenogenic volume stable collagen matrix in people with Edentulous Alveolar Ridge, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Aimetti (00390116331546, mario.aimetti@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.